Research Study of Visilizumab for Treatment of Acute Graft Versus Host Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2006-08-31

Brief Summary

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The purpose of this Phase I/II, open-label, dose-escalation study is to evaluate an investigational monoclonal antibody administered as a first-line therapy to patients with acute, Grade II, III, or IV graft-versus-host disease (GVHD). Patients will be eligible for enrollment within 24 hours of beginning standard steroid treatment. The research is being conducted at up to 10 clinical research sites in the US.

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Detailed Description

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A Phase I/II, open-label, dose-escalation pilot study designed to obtain preliminary safety, pharmacokinetic (PK) and efficacy information on visilizumab administered as a first-line therapy to patients with acute, Grade II, III, or IV graft-versus-host disease (GVHD). It is anticipated that up to 34 patients at up to 10 study centers could be eligible for enrollment in this study. Patients will be eligible for enrollment within 24 hours of beginning standard steroid treatment (2 mg/kg of methylprednisolone IV, or 10 mg/kg hydrocortisone IV, per day). Steroids will be rapidly tapered over one week following visilizumab administration.

Conditions

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Graft vs Host Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Visilizumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who develop Grade II, III, or IV acute GVHD following allogeneic hematopoietic cell transplantation
* Patients receiving GVHD prophylaxis including cyclosporine or tacrolimus
* Clinical findings: skin thickening, joint contraction, oral ulceration, diarrhea.
* Patients with an onset date of acute GVHD that is less than or equal to 100 days posttransplant.

Eligible Sex

ALL

Accepts Healthy Volunteers

No